Flosonics Medical (R/A 1929803 ONTARIO CORP.) recalls FloPatch FP120
Reason for recall
Flowmeter patch as a human readable expiry date on the outer shipping packaging that reads 2025-06-20 when it should read 2026-06-20.
Affected product
Check your device
Enter a lot, serial, REF, or UDI number from your device's label to check it against this recall's listed codes.
Affected products & lots
- FloPatch FP120, REF:FP120-FOT01-005UDI-DI 10627987360148.Affected lot03250602
What the firm is doing
On 8/7/2025, recall notices were emailed to customers who were asked to do the following: 1. Customers to confirm receipt of recall notice. 2. Customers should dispose of the outer shipping packaging. 3. If desired, customers may request replacement product. For questions, please contact: cchin@flosonicsmedical.com
DistributionShow detailsHide
US Nationwide distribution in the state of California.
Use of the product is not likely to cause adverse health consequences.
Sources & references
- FDA enforcement recordOfficial FDA database entry for Z-2517-2025
- FDA 510(k) clearance · K200337The device's official FDA premarket clearance record
- FDA 510(k) clearance · K223843The device's official FDA premarket clearance record
- FDA device classification · DPWOfficial FDA classification for this device type
- CFR regulation · 21 CFR 870.2100The federal regulation governing this device
- FDA recall announcementSearch FDA.gov for the official press announcement
- Find Flosonics Medical (R/A 1929803 ONTARIO CORP.)Search for the manufacturer's official notice
- News coverageRecent reporting on this recall and manufacturer
- openFDA data recordThe raw JSON record this page is built from
Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.
Taylor Coteus is RecallWatch's Legal News Analyst, covering FDA medical-device enforcement and patient-safety litigation. He reviews every recall against the FDA's official openFDA record before it is published and is responsible for corrections and editorial accuracy.
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